Noninferiority Randomized Controlled Clinical Trial Assessing the Antiplaque Efficacy of Fatty Acids–Based Mouthrinse

Abstract

Objectives: The market offers many plaque-controlling mouthrinse options, but recent research reveals fatty acids' antimicrobial potential. Despite limited evidence on their antiplaque effects, fatty acids are intriguing for oral care innovation. Material and Methods: This noninferiority randomized clinical trial assessed the antiplaque efficacy of a fatty acids–based (FAG) compared to stannous fluoride (SF) mouthrinse in experimental gingivitis induced by 14 days of oral hygiene cessation. Participants used assigned treatments twice daily for 14 days. Full Mouth Plaque and Bleeding Scores (FMPS/FMBS) served as primary outcomes. Statistical analyses encompassed parametric and nonparametric methods, as well as logistic regression models. Results: Thirty-one volunteers (22.9 ± 1.6 years, 58.1 female) completed the trial, split between FAG (n = 15) and SF (n = 16) groups. Experimental gingivitis increased in both groups, with rates of 60.0% and 50.0% for FAG and SF, respectively. After the 14-day intervention, FMPS and FMBS were reduced in both groups compared to the post-induction phase, confirming the noninferiority of FAG. Specifically, FAG's FMPS was 39.7% ± 13.8% with FMBS at 28.9% ± 16.9%, while SF's FMPS was 43.2% ± 14.9% with FMBS at 21.4% ± 11.9%. No significant FMPS/FMBS differences were observed overtime, and there were also no significant differences in gingivitis rates throughout the trial. Crude and adjusted models, accounting for baseline FMPS, age and gender, reiterated the lack of significant association between outcomes and treatments. The adjusted odds ratio was 0.71 (p = 0.662). Conclusion: This study establishes the noninferiority of fatty acids–based relative to SF mouthrinse in an experimental gingivitis model. Fatty acids offer promising avenues for oral care enhancement, necessitating further investigation and validation in broader real-life scenarios.